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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Main results already published |
Unique ID issued by UMIN | UMIN000030392 |
Receipt No. | R000034259 |
Scientific Title | Development of treatment strategy for CKD-MBD by multilateral mechanism of ethelcarcitrate hydrochloride |
Date of disclosure of the study information | 2018/01/01 |
Last modified on | 2020/12/18 |
Basic information | ||
Public title | Development of treatment strategy for CKD-MBD by multilateral mechanism of ethelcarcitrate hydrochloride | |
Acronym | The DUET study | |
Scientific Title | Development of treatment strategy for CKD-MBD by multilateral mechanism of ethelcarcitrate hydrochloride | |
Scientific Title:Acronym | The DUET study | |
Region |
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Condition | ||||
Condition | Secondary hyperparathyroidism | |||
Classification by specialty |
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Classification by malignancy | Others | |||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To investigate the efficacy of etelcalcetide in hemodialysis patients with secondary hyperparathyroidism |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Ratio of achievement of more than 50% reduction and under 240pg/dl in intact parathyroid hormone (iPTH) after 12 weeks of treatment |
Key secondary outcomes | -Ratio of achievement of 60<=iPTH<=240 after 12 weeks of treatment
-Ratio of achievement of more than 30% reduction in iPTH after 12 weeks of treatment -Ratio of achievement of more than 30% reduction and 60<=iPTH<=240 after 12 weeks of treatment -Ratio of achievement of more than 50% reduction in iPTH after 12 weeks of treatment -Change in iPTH after 2, 4, 6, 8, 10 and 12 weeks of treatment relative to the baseline -Change in CalciProtein Particle (CPP) and Fibroblast Growth Factor 23 (FGF23) after 6 and 12 weeks of treatment relative to the baseline among treatment groups -Change in Ca, P, CaXP and Mg after2, 4, 6, 8, 10 and 12 weeks relative to the baseline among treatment groups -Change in Bone Specific Alkaline Phosphatase (BAP) and Tartrate-resistant Acid Phosphatase 5b (TRACP5b) after one year of treatment relative to the baseline among treatment groups -Comparison of aortic calcification before and after observation -Ca, P and iPTH levels after one year of treatment -Comparison of normalized ratio of hypocalcemia between VitD and calcium preparations -Adverse events |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | YES |
Dynamic allocation | YES |
Institution consideration | Institution is considered as adjustment factor in dynamic allocation. |
Blocking | YES |
Concealment | Central registration |
Intervention | ||
No. of arms | 3 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Etelcalcetide+active Vitamin D for 12weeks | |
Interventions/Control_2 | Etelcalcetide+oral calcium (calcium carbonate) for 12weeks | |
Interventions/Control_3 | Control [active Vitamin D + oral calcium (calcium carbonate)] for 12weeks | |
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1.patients on maintenance hemodialysis 3 times a week
2.patients with more than one-year hemodialysis vintage 3.patients who are judged stable 4.older than 20 years and younger than 100 years 5.iPTH >=240 pg/ml within 4 months 6.corrected Ca >=8.4mg/dl at enrollment 7.patients who are able to write informed consent |
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Key exclusion criteria | 1.patients who have been prescribed etelcalcetide before
2.bisphosphonate users within 24 weeks 3.primary hyperparathyroidism 4.undergoing parathyroidectomy or intervention therapy to parathyroid within 90 days before enrollment 5.scheduled parathyroidectomy, intervention therapy to parathyroid or kidney plantation 6. pregnant or breast feeding 7. patients who are deemed unsuitable by a physician, for instance cancer, severe infection and severe complication 8. patients who are prescribed Maxacalcitol, over 10[micro]gx3/week at obtainment of IC 9. patients who are prescribed Calcitriol, over 0.75[micro]gx3/week at obtainment of IC 10. patients who are prescribed other active VitD, over half of maximum dose at obtainment of IC 11. patients who are prescribed precipitated calcium carbonate, over 3g/day at obtainment of IC |
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Target sample size | 120 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Nagoya University Graduate School of Medicine, Internal Medicine | ||||||
Division name | Nephrology | ||||||
Zip code | 4648550 | ||||||
Address | 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan | ||||||
TEL | +81-52-744-2192 | ||||||
marus@med.nagoya-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Nagoya University Graduate School of Medicine, Internal Medicine | ||||||
Division name | Nephrology | ||||||
Zip code | 4648550 | ||||||
Address | 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan | ||||||
TEL | +81-52-744-2192 | ||||||
Homepage URL | |||||||
Kato07@med.nagoya-u.ac.jp |
Sponsor | |
Institute | Nagoya University Graduate School of Medicine, Nephrology |
Institute | |
Department |
Funding Source | |
Organization | ONO PHARMACEUTICAL CO., LTD. |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Nagoya University |
Address | 65 Tsurumai Showa Nagoya |
Tel | 052-741-2111 |
ethics@med.nagoya-u.ac.jp |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | 120 |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Main results already published | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034259 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |